Updating the National Vaccine Plan: A roadmap for the next decade A National, not Federal, Plan December 11, 2009

Outline of Presentation Development of National Vaccine Plan (NVP) background current status timeline for completion IOM recommendations Implementation Plan

Developing a National Vaccine Plan “The plan shall establish priorities … and describe an optimal use of resources to carry out such priorities, and describe how each of the various departments and agencies will carry out their functions in consultation and coordination with the Program and in conformity with such priorities.” First plan published in 1994; no action steps, timelines, or accountable parties for implementation.

Vision for National Vaccine Plan Update Summarize current priorities for vaccine- and immunization-related research, development and use Will coordinate with national health objectives (HealthyPeople 2020, now in development - http://www.healthypeople.gov/hp2020/) Contribute to efforts to prioritize the use of existing resources Identify needs for new resources for the next 10 years A National, not Federal government, Plan

National Vaccine Plan Revision Timeline Current and Projected Activities OCT NOV DEC JAN FEB MAR APR MAY JUN JULY AUG SEP OCT NOV 2010 HHS/Federal Activities Jan-April, 2009 HHS received, addressed 466 public comments; Hosted 3 public meetings Complete Strategic Plan Version 2 with Priorities Complete Final Strategic Plan Complete Implementation Plan Advisory Committee Activities Feb 3-4, 26 NVAC mtg, call On priorities RAND stakeholder Interviews on roles External Activities/ Stakeholders Dec 11 IOM Report Public Comment

2008 Draft Strategic National Vaccine Plan Goals Develop new and improved vaccines Enhance the safety of vaccines and vaccination practices Support informed vaccine decision-making by the public, providers, and policy-makers Ensure a stable supply of recommended vaccines and achieve better use of existing vaccines to prevent disease, disability and death in the United States (NEW) Increase global prevention of death and disease through safe and effective vaccination

Goal 1: Develop New and Improved Vaccines Develop a list of priority vaccines for domestic and global health use. Strengthen the science base for the development and licensure of new vaccines.

Goal 2: Enhance the Safety of Vaccines and Vaccination Practices Enhance timely detection and verification of vaccine safety signals. Improve scientific knowledge about why and among whom  vaccine adverse events occur.

Goal 3: Support vaccine informed decision-making by the public, providers, and policy makers Increase awareness of vaccines, vaccine-preventable diseases, and benefits/risks of immunization among the public, providers, and other stakeholders. Establish an ongoing public engagement process to inform policy-making and research activities.

Goal 4: Ensure a stable supply of recommended vaccines and achieve better use of vaccines to prevent disease, disability and disease in the United States Create an adequate and stable vaccine supply for public health preparedness and recommended routine use purposes. Reduce barriers for providers and consumers to facilitate access to vaccines. Increase the use of interoperable health information and electronic medical records to improve the delivery and financing of vaccines.

Goal 5: Increase global prevention of death and disease through safe and effective vaccination Improve global surveillance for vaccine-preventable diseases and strengthen global health information systems to monitor vaccine coverage, effectiveness, and safety. Support global introduction and availability of new and under-utilized vaccines to prevent diseases of public health importance.

*See http://www.iom.edu/Activities/PublicHealth/NatVaxPlan.aspx Institute of Medicine: Review of Priorities for the National Vaccine Plan Stakeholder Meetings Goal 4 (July 24, 2008) Goal 1 (December 1, 2008) Goal 3 (February 2, 2009) Goal 2 (April 14, 2009) Goal 5 (June 4, 2009) Final report December 11, 2009* *See http://www.iom.edu/Activities/PublicHealth/NatVaxPlan.aspx

Goal 1 – Vaccine Development Selected Recommendations from 12/11/09 IOM Report on Priorities for the National Vaccine Plan Goal 1 – Vaccine Development Vaccine prioritization Address non-infectious diseases’ vaccines Goal 2 – Vaccine Safety Develop prioritized research agenda for all federal agencies and stakeholders Goal 3 – Communications/Informed Decision-Making Develop national communications strategy The IOM reported 20 priorities, of which 19 related to the existing Goals and Objectives in the draft strategic Plan. The 20th, about coordination in general, is an overarching recommendation I will present separately.

Selected Recommendations from 12/11/09 IOM Report on Priorities for the National Vaccine Plan (2) Goal 4 – Vaccine Supply and Use Assure a stable vaccines’ supply Eliminate financial barriers to vaccination Assume active role in national health information initiative Assess national health reform outcomes’ role in the Plan Goal 5 – Global Vaccine Issues Support low-middle income countries’ capacity building to implement new vaccines Provide expertise and resources to incorporate new vaccines, strengthen infrastructure, and achieve higher vaccination levels

Selected Recommendations from 12/11/09 IOM Report on Priorities for the National Vaccine Plan (3) Recommendation 6-1: The Secretary of HHS should actively demonstrate the Department’s support for the National Vaccine Plan by: (1) clarifying its primacy as the strategic planning tool applicable to all federal agencies with roles in the National Vaccine Program, and (2) allocating the resources necessary to assure robust planning and implementation, with coordination by the National Vaccine Program office.

Patient Protection and Affordable Care Act 2010 and Immunization – Selected Topics Expands health insurance access All ACIP-recommended vaccines shall be included/paid for in new private insurance plans without cost-sharing Medicaid: Incentive eligible for 1% FMAP increase) for states that cover USPSTF A and B and ACIP services with no cost sharing.  Effective 2013 Medicare: No cost sharing for USPSTF A and B services; includes Federally approved and recommended vaccines and their administration. Effective July 2011 Comptroller General to study Medicare part D regarding any barriers to vaccines; report to Congress by 06/01/2011 HHS may develop contracts for states to purchase [additional] vaccines for adults

NVAC Criteria to Recommend Priorities for the draft strategic National Vaccine Plan Feasibility (financial and technical) Potential impact on morbidity and mortality Strategic opportunity (likely to require, motivate multi-stakeholder involvement) Public salience (derived from public engagement meetings’ priority areas)

Conclusions from 2009 National Vaccine Public Engagement Meetings Values that mattered most to participants Achieving Equity Emphasizing Safety Promoting Education and Awareness Protecting Our Homeland Protecting the Most Vulnerable Areas of activity that best fit with top values Make vaccines affordable and available to everyone. Maintain high rate of vaccination of children. Improve monitoring of disease and vaccines. Improve vaccine safety. Assure there is enough vaccine. Key findings from these three public engagement sessions can inform vaccine planning efforts and the revision of the National Vaccine Plan. Participants offered some clear advice about which values and priorities they would like to see reflected in the government’s decision-making in renewing the plan. 18

Implementation Plan Development Missing from 1994 Plan Will add action steps for each strategy, with responsible parties to assure accountability, annual review, and a mid-course (5 year) review with National Vaccine Advisory Committee (NVAC) Should be written with all stakeholders present in appropriate interest groups, e.g., Goal-specific by end of 2010

Summary National Vaccine Plan strategic vision for 10 years to be completed in 2010 Implementation Plan with action steps to follow, written by all stakeholders